Apparatuses and methods for producing enriched fibrillated tissue matrices

ABSTRACT

Apparatuses and methods for producing enriched fibrillated tissue matrices are disclosed herein. Some embodiments include a method including subjecting tissue in a carrier liquid to a fibrillation pressure while maintaining a temperature of the tissue and the carrier liquid to at or below a safe zone temperature; inducing a phasic shift and rapid release of water and biological components from the tissue through a disruptive boil and tissue explosion process to produce a fibrillated tissue matrix; and recapturing the water and biological components.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit and priority of U.S. ProvisionalApplication Ser. No. 62/533,648, titled “APPARATUSES AND METHODS FORPRODUCING ENRICHED FIBRILLATED TISSUE MATRICES”, filed on Jul. 17, 2017,which is hereby incorporated by reference herein in its entiretyincluding all references and appendices cited therein, for all purposes.

FIELD OF THE INVENTION

The present disclosure is directed generally, in some embodiments, tothe preparation of fibrillated tissue matrices, and more specifically,but not by limitation to apparatuses and methods for producingfibrillated tissue for use in medical treatments such as tissueallograft procedures.

SUMMARY

According to some embodiments, the present disclosure is directed to amethod comprising placing a carrier liquid into a pressure vessel,introducing tissue into the carrier liquid, pressurizing the carrierliquid and the liquid within the pressure vessel to a critical pressure,selectively controlling a temperature of within the pressure vessel soas to preserve biological components of the tissue during a boiledliquid expanding vapor explosion (BLEVE) process, and depressurizing thepressure vessel to trigger the BLEVE process to produce a fibrillatedtissue matrix and a vaporized fluid comprising at least a portion of thebiological components. In the full sense of the application, or tobetter define “boil” in the context of this disclosure, the embodimentdefines a method to change from a liquid to a gaseous state, producingbubbles of gas that rise to the surface of the liquid, agitating it asthey rise, with temperature a balanced equilibrium of pressure to attainthose results.

According to some embodiments, the present disclosure is directed to amethod comprising subjecting tissue in a carrier liquid to afibrillation pressure while maintaining a temperature of the tissue andthe carrier liquid to at or below a safe zone temperature; inducing aphasic shift and rapid release of water and biological components fromthe tissue through a disruptive boil and tissue explosion process toproduce a fibrillated tissue matrix; and recapturing the water andbiological components.

According to some embodiments, the present disclosure is directed to asystem/apparatus comprising a pressure vessel that can be selectivelycontrolled with a control system relative to pressure and temperature tofibrillate a tissue disposed inside the pressure vessel, the tissuebeing disposed in a carrier fluid, the tissue being fibrillated usingboiled liquid expanding vapor explosion (BLEVE) through pressurizationof the pressure vessel and rapid decompression of the pressure vessel,the temperature within the pressure vessel being controlled so as topreserve biological components of the tissue during BLEVE, and reclaimfor recombination and subsequent lyophilization as an intact wholematerial in a form of a fibrillated tissue matrix that results frompressure modified processing with dehydration as a summative finaldifference.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of the present technology are illustrated by theaccompanying figures. It will be understood that the figures are notnecessarily to scale and that details not necessary for an understandingof the technology or that render other details difficult to perceive maybe omitted. It will be understood that the technology is not necessarilylimited to the particular embodiments illustrated herein.

FIG. 1 is a schematic diagram of a system of the present disclosure.

FIG. 2 is a flowchart of an example method of the present disclosure.

FIG. 3 is a flowchart of an example sub-method of the present disclosurethat reflects the use of a fibrillated tissue matrix produced in themethod of FIG. 2.

FIG. 4 is a flowchart of another example method of the presentdisclosure.

FIG. 5 is a flowchart of another example method of the presentdisclosure illustrating an optional allograft production process.

FIG. 6 is a flowchart of another example method of the presentdisclosure involving cold fracturing of a tissue.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

Generally speaking, the present disclosure is directed to apparatusesand methods for producing fibrillated tissue matrices. Example methodscomprise any combination or permutation of tissue fibrillation, matrixrecombination, and lypholization—just to name a few. The resultantenriched, fibrillated tissue matrices are exosome rich and cytokinerich, and can be used in medical procedures such as cartilage allograftprocedures.

In some embodiments, fibrillated tissue is created using a pressurevessel apparatus. Tissue segments are placed into the pressure vesselapparatus and the pressure vessel apparatus is at least partially filledwith a carrier fluid. The pressure vessel apparatus is configured insome embodiments to pressurize its contents while maintaining atemperature of the contents approximately within a safe zone temperaturerange. The maintenance of the contents of the pressure vessel at thesafe zone temperature range reduces a likelihood of deleterious damageto tissue components such as exosomes, cytokines, growth factors,sulfated proteoglycans, and other similar tissue components that mightresult from an increase in temperature when a corresponding increase inpressure within the pressure vessel apparatus is achieved. That is, thepressure vessel apparatus comprises a cooling means that offsets acorresponding increase in temperature within the pressure vessel due toincreased pressure in the pressure vessel apparatus.

When the pressure vessel apparatus has been pressurized to afibrillating pressure, the pressure inside the pressure vessel apparatusis rapidly released causing the tissue segments to fibrillate in aprocess known as boiled liquid expanding vapor explosion (“BLEVE”).

In one or more embodiments, cartilage (or any tissue) and suitablecarrier such as saline are combined into a thick-wall pressure vesselthat can be highly pressurized and safely contained. Pressure isincreased in the vessel up to a desire fibrillation pressure. Once thefibrillation pressure has been achieved, pressure is rapidly reduced,resulting in a phasic shift and rapid release of water from the tissuethrough a disruptive boil and tissue explosion.

FIG. 1 is a schematic view of an example pressure vessel apparatusconstructed in accordance with the present disclosure. The pressurevessel apparatus 100 comprises a pressure vessel 102, a cooling assembly104, a pump 106, and a control system 108. Additional or fewercomponents than those illustrated can be utilized as would be apparentto one of ordinary skill in the art with the present disclosure beforethem.

In some embodiments, the pressure vessel 102 comprises a thick-wallvessel of any shape and/or size, constrained by design and/ormanufacturing constraints, such as tissue and carrier fluid processingvolume. The pressure vessel 102 can be manufactured from any suitablematerial such as stainless steel, although other materials that would beknown to one of ordinary skill in the art with the present disclosurebefore them are likewise contemplated for use in accordance with thepresent disclosure.

The pressure vessel 102 comprises a port 110 that allows for either orboth of inputting of tissue segments and carrier fluid and/ordischarging of fibrillated tissue matrices. In some embodiments, theport 110 can function as a one-way valve that allows fibrillated tissueto be discharged when a pressure in the pressure vessel 102 reachesapproximately a fibrillating pressure. In another embodiment, the port110 is an actuated valve that opens under control from the controlsystem 108.

The tissue segments and carrier fluid can be introduced through anotherinput port, such as secondary port 112, or by any other means that wouldbe known to one of ordinary skill in the art. The secondary port 112 canalso couple with a condenser as described below, which will reintroducecondensed vaporized biological components back into the pressure vessel102, in some embodiments. The respective use of the port 110 orsecondary port 112 for introduction or release of materials is based ondesign choice as would be appreciated by one of ordinary skill in theart with the present disclosure before them.

The cooling assembly 104 is in fluid communication with the pressurevessel 102. The cooling assembly 104 can comprise any suitable coolingmeans that allows a temperature within the pressure vessel 102 to beregulated. This could include liquid heat transfer where the pressurevessel 102 is in contact with a cooling fluid of the cooling assembly104. Another example would comprise the use of a coiled tube heatexchanger coil wrapped around the pressure vessel 102. In one or moreembodiments a means for cooling can be integrated into the pressurevessel 102 itself.

In some embodiments, the pump 106 is utilized to increase a pressurewithin the pressure vessel 102. The pump 106 can pressurize the pressurevessel 102 with any fluid, such as air, although other fluids thatenhance tissue component extraction and/or preservation can also beutilized. In one or more embodiments, the carrier fluid can comprise,for example, nitric oxide, which has a relatively short half-life and ismaterially advantageous to cells and vascular tissue for dilation andflow of metabolites. The use of nitric oxide provides biologicaladvantages and enhancements relative to saline.

The control system 108 can comprise any computing system, such as aserver or specific-purpose (e.g., specifically programmed) computingsystem. The control system 108 can comprise computing components such asa processor, memory, display and other related components that would beknown in the art. The memory stores executable instructions and logicfor storing, for example, algorithms that control the pressure withinthe pressure vessel 102 and the temperature within the pressure vessel102. Thus, the control system 108 can comprise one or more sensors (suchas a pressure sensor 114A and a temperature sensor 114B) that areassociated with the pressure vessel 102 and are configured to monitorany of pressure and temperature inside the pressure vessel 102. Theprocessor can execute the instructions stored in memory to controloperations of the pressure vessel 102 to fibrillate the tissue segmentsaccording to the present disclosure.

In one embodiment, the control system 108 continuously monitors thepressure and temperature within the pressure vessel 102 allowing apressure within the pressure vessel 102 to reach approximately at orabove a fibrillating pressure within the pressure vessel 102, whilesimultaneously maintaining a temperature within the pressure vessel 102at a desired temperature range. Example pressures that can be usedinclude placing the tissue segments at, near, or approximately above acritical pressure, which would induce a phase change through the use ofBLEVE. Example operating temperatures would be between zero and 100degrees Celsius, inclusive. In one or more embodiments, the temperaturewithin the pressure vessel is brought as low as possible while allowingpressure inside the pressure vessel to increase to a point at whichBLEVE can occur by decompression. In other embodiments, pressuresranging from approximately 300-600 MPa, inclusive and from approximately100-400 MPa, inclusive are contemplated for use.

Thus, the control system 108 can either directly or indirectly controlthe pump 106 and cooling assembly 104 to ensure that the pressure andtemperature are within desired operating ranges. For example, if thepressure increases causes unexpected increases in temperature, thecontrol system 108 can reduce the pressure or the cooling assembly 104can be controlled to reduce the temperature to a desired ranges.

When pressure inside the pressure vessel 102 reaches the fibrillatingpressure, the control system 108 opens the port 110, rapidlydecompressing the pressure vessel 102 and causing BLEVE of the tissuesegments to fibrillate the tissue segments. During fibrillation,biological constituent parts within the tissue segments separated andcaptured. The fibrillated matrix is a desiccated residual matrix, whilethe biological constituent parts such as exosomes, cytokines, growthfactors, sulfated proteoglycans, and other similar tissue components,separate from the fibrillated matrix and are vaporized in the BLEVEprocess. In some embodiments, the boiled/vaporized fluid can becondensed in a condenser 116, allowing the biological constituent partsto return to a liquid form and enter the carrier liquid. Thisevaporative/condensing process results in the capture of a biologicalconstituent distillate that is rich in exosomes, cytokines, growthfactors, sulfated proteoglycans, and other similar tissue components.

According to some embodiments, the desiccated, fibrillated matrix isreconstituted by combining the matrix with the enriched distillate toproduce an enriched fibrillated matrix that has been enriched inconcentration relative to the native, but reformulated to a matrix withincreased surface areas, greater porosity, and more plasticconformation.

In sum, the process creates an infiltrable matrix (e.g., fibrillatedtissue matrix), that has been replenished with its natural biologicconstituents, and in the process enhances surface area, enrichesexchange of biological fluids, and accelerates integration whenimplanted.

The concepts disclosed herein can be utilized in combination with othersystems. For example, a fibrillated product produced that has beenreconstituted in accordance with the present disclosure can be used asan allograft. Prior to use, this allograft can be placed in a centrifugealong with patient specific protein rich platelets (PRP) and spun at asufficient rate to pellet and flatten the matrix. This process alsofurther enriches the matrix with patient specific cells, cell products,and cytokines that are native to the host, so as to produce a chimericgraft that is matrix allograft and cytokine autologous.

In operation, a carrier fluid 118, such as a saline solution isintroduced into the pressure vessel 102. Next, tissue segments 120 areintroduced into the carrier fluid 118. This could comprise, for example,shavings of a tissue such as cartilage. The control system 108 controlsthe pump 106 to increase pressure within the pressure vessel 102. Thetemperature and pressure sensors (e.g., one or more sensors 114A and114B) are used to allow the control system 108 to continuously monitorpressure and temperature within the pressure vessel 102. As the pressureincreases a corresponding increase in temperature begins. The controlsystem 108 then controls the cooling assembly 104 to control thetemperature within the pressure vessel 102 to within a desiredtemperature range. In some embodiments, this range comprises aphysiologic range comprising between approximately 35-41 degreesCentigrade, inclusive, to take advantage of pyrogenic cytokines andtheir effective activity on cell shedding and reaction during thepreparation and extraction phases.

Again, this temperature range allows for preservation of biologicalcomponents such exosomes and growth factors in the tissue segments 120that might otherwise be deleteriously damaged by high temperature withinthe pressure vessel 102. Once a fibrillating pressure is reached withinthe pressure vessel 102, the control system 108 can activate the port110 to open causing a rapid decompression within the pressure vessel 102to cause BLEVE, which in turn converts the tissue segments 120 into afibrillated matrix. This fibrillated matrix is dehydrated during theBLEVE process when water and biological components are separated fromthe fibrillated matrix.

In some embodiments the biological components of the tissue segments 120and carrier fluid 118 that are vaporized during BLEVE are condensedusing the condenser 116. This condensate (e.g., enriched carrier fluid)is then pumped or otherwise delivered back into the pressure vessel 102or any other suitable container to create an enriched carrier fluid.That is, the biological components of the tissue segments that separatefrom the fibrillated matrix during BLEVE will condense back into thecarrier fluid. This enhanced carrier fluid can be used to reconstitutethe fibrillated matrix to produce an enriched fibrillated matrix that isready for use in any number of medical procedures or to createimplantable objects.

In one embodiment, the enriched carrier fluid (e.g., biologicalconstituent distillate) is captured and reused at a later time torehydrate the dehydrated, fibrillated tissue matrix, such as anysuitable time prior to using the fibrillated matrix in a patient. Theenriched carrier fluid can be stored in a pharmaceutically acceptablemanner until required for rehydration of the dehydrated, fibrillatedtissue matrix.

By way of non-limiting example, the fibrillated matrix and/or enrichedfibrillated matrix can be used to create a cartilage allograft used tofor grafting into a patient. In some embodiments, additional compoundscan be introduced into the fibrillated matrix such as a tissue growthenhancing product, a medicament such as an anti-rejection preparation, afiller, or any combinations thereof.

In sum, the pressure vessel apparatus 100 includes a pressure vesselthat can be selectively controlled with a control system relative topressure and temperature to fibrillate a tissue disposed inside thepressure vessel. In various embodiments the tissue is disposed in acarrier fluid and the tissue being fibrillated using boiled liquidexpanding vapor explosion (BLEVE) through pressurization of the pressurevessel and rapid decompression of the pressure vessel. In one or moreembodiments the temperature within the pressure vessel is controlled soas to preserve biological components of the tissue during BLEVE, andreclaim for recombination and subsequent lyophilization as an intactwhole material in a form of a fibrillated tissue matrix that resultsfrom pressure modified processing with dehydration as a summative finaldifference.

FIG. 2 is a flowchart of an example method of the present disclosure.The method includes a step 202 of placing a carrier liquid into apressure vessel. This can include introducing saline or anotherbiologically compatible (suitable for use in vivo in a patient) liquidinto a pressure vessel.

Next, the method includes a step 204 of introducing tissue into thecarrier liquid. This can include placing particulate preparations of thetissue (of any size desired depending on the application) such asshavings, into the carrier liquid. In some instances, steps 202-204 arecombined such that the tissue is mixed into the carrier liquid prior tointroduction into the pressure vessel.

In various embodiments, the method includes a step 206 of pressurizingthe carrier liquid and the liquid within the pressure vessel to acritical pressure. Example pressures for the pressure vessel aredisclosed supra. In combination with step 206, the method includes astep 208 of selectively controlling a temperature of within the pressurevessel so as to preserve biological components of the tissue during aboiled liquid expanding vapor explosion (BLEVE) process. As notedthroughout, the temperature can be controlled by an temperaturecontrolling means desired that will allow the contents of the pressurevessel to remain at approximately zero to 100 degrees Celsius duringpressurization.

In one or more embodiments, the method includes a step 210 ofdepressurizing the pressure vessel to trigger the BLEVE process toproduce a fibrillated tissue matrix and a vaporized fluid comprising atleast a portion of the biological components. This can be accomplishedby releasing a valve on the pressure vessel such that a decompressionoccurs that is sufficient to trigger BLEVE.

The method of FIG. 2 can further comprise an optional sub-method(illustrated in dotted line) for capturing enriched carrier fluid. Thesub-method includes a step 212 capturing the vaporized fluid using, forexample, a condenser, and a step 214 of condensing the vaporized fluidinto a biological constituent distillate. The biological constituentdistillate includes the carrier fluid plus any liquid or particulatebiological components liberated from the tissue or otherwise producedduring BLEVE.

FIG. 3 is another example method of the present disclosure that reflectsthe use of a fibrillated tissue matrix produced in the method of FIG. 2.The method of FIG. 3 includes a step 302 of enriching the fibrillatedtissue matrix. The enrichment of the fibrillated tissue matrix isaccomplished by applying the biological constituent distillate to thefibrillated tissue matrix. In one embodiment, this includes soaking thefibrillated tissue matrix in the biological constituent distillate. Insome embodiments, the combination is performed when the fibrillatedtissue matrix is inside the pressure vessel. For example, the condenserand/or pump can reintroduce the biological constituent distillate backinto the pressure vessel where the dehydrated, fibrillated tissue matrixis located. In another embodiment, the biological constituent distillateis collected and processed prior to usage. This can include allowing thebiological constituent distillate to be analyzed for biologicalcomponent levels, as well as further enhancement through additions ofother components such as additional exosomes, cytokines, growth factors,sulfated proteoglycans, and other similar tissue components. Otherproducts can also be added to the biological constituent distillate suchas medicaments.

Next, the method includes a step 304 of dehydrating the enrichedfibrillated tissue matrix. A fibrillated tissue matrix can be combinedwith the biological constituent distillate, and this resultant productcan be dried. An example use of this enriched and dehydrated materialincludes embed the enriched and dehydrated fibrillated tissue matrix inan artificial thrombin to create a glue. Advantageously, this allows acoated (e.g., enriched) dried material to be suspended in the tissuesealant, and as that sealant is replaced, to free the growth factorswithin that have eluted and leaked into the underlying fibrillatedtissue matrix.

In addition to adding components to the biological constituentdistillate, the fibrillated tissue matrix can also be processed such asthrough the addition of fillers, medicaments, or exosomes, cytokines,growth factors, sulfated proteoglycans, and other similar tissuecomponents. Thus, the method includes a step 306 of further enrichingany of the enriched fibrillated matrix or the dehydrated fibrillatedtissue matrix with any of a tissue growth enhancing product, amedicament, a filler, or any combinations thereof. This process canoccur prior to or after step 304.

As noted above, the method can also include an optional step 308 ofembedding the enriched and dehydrated fibrillated tissue matrix in anartificial thrombin to create a glue. This process can further includeimplanting the resultant product in a patient.

FIG. 4 is a flowchart of an example method of using a fibrillated tissuematrix of the present disclosure. In one example embodiment, the methodincludes a step 402 of fabricating an allograft implant using thefibrillated tissue matrix. This can include a dehydrated fibrillatedtissue matrix or a rehydrated fibrillated tissue matrix. In someembodiments, this step occurs after either step 304 of FIG. 3, postrehydrating of the fibrillated tissue matrix, or after step 210 of FIG.2, post creation of the fibrillated tissue matrix using a temperaturecontrolled BLEVE process.

In various embodiments, the tissue used to create the fibrillated tissuematrix is obtained from a patient receiving the allograft implant suchthat the allograft implant is a chimeric graft that is cytokineautologous. This reduces the likelihood that the allograft implant willbe rejected by the patient.

In some embodiments, the method includes a step 404 of enriching theallograft implant with biological constituent distillate or otherexogenous biological components if no biological constituent distillatewas recovered during tissue fibrillation. Next, the method includes astep 406 of implanting the allograft implant in any medically acceptableprocess. Again, this allograft implant can include a rehydrated (e.g.,enriched) fibrillated tissue matrix.

FIG. 5 is a flowchart of another example method of the presentdisclosure. The method includes a step 502 of subjecting tissue in acarrier liquid to a fibrillation pressure while maintaining atemperature of the tissue and the carrier liquid to at or below a safezone temperature. In sum, the fibrillation pressure is a pressuresufficient to convert the tissue into a fibrillated matrix using BLEVE.

The method includes a step 504 of inducing a phasic shift and rapidrelease of water and biological components from the tissue through adisruptive boil and tissue explosion (BLEVE) process to produce afibrillated tissue matrix. Next, the method includes a step 506 ofrecapturing the water and biological components for reintroduction orlater use.

FIG. 6 illustrates a flowchart of another example method of the presentdisclosure. This method in general includes freezing and blunt forceimpact to the tissue prior to BLEVE. For example, the method can includea step 602 of freezing a tissue. This can include subjecting the tissueto liquid nitrogen for a period of time. In general, this processincludes reducing a temperature of the tissue to a fracturingtemperature. The specific fracturing temperature is based on the tissue,as would be understood by one of ordinary skill in the art with thepresent disclosure before them. Once a desired temperature is reached,the method can include a step 604 of applying a mechanical force to thecold tissue, such as compression slamming of the cold tissue. This caninclude impacting the cold tissue with a hydraulic or other similar typeof mechanical press to induce a fracturing of the cold tissue. Thepressures used to fracture the cold tissue depend on the mechanicalproperties of the cold tissue and/or the extent of fracturing desired.The method can also include a step 606 of subjecting the cold fracturedtissue to a temperature controlled BLEVE process to create a fibrillatedtissue matrix, as well as a step 608 of enriching the fibrillated tissuematrix with biological components created during the temperaturecontrolled BLEVE process.

While this technology is susceptible of embodiment in many differentforms, there is shown in the drawings and has been described in detailseveral specific embodiments with the understanding that the presentdisclosure is to be considered as an exemplification of the principlesof the technology and is not intended to limit the technology to theembodiments illustrated.

Although the terms first, second, etc. may be used herein to describevarious elements, components, regions, layers and/or sections, theseelements, components, regions, layers and/or sections should notnecessarily be limited by such terms. These terms are only used todistinguish one element, component, region, layer or section fromanother element, component, region, layer or section. Thus, a firstelement, component, region, layer or section discussed below could betermed a second element, component, region, layer or section withoutdeparting from the teachings of the present disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be necessarily limiting of thedisclosure. As used herein, the singular forms “a,” “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. The terms “comprises,” “includes” and/or“comprising,” “including” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

Example embodiments of the present disclosure are described herein withreference to illustrations of idealized embodiments (and intermediatestructures) of the present disclosure. As such, variations from theshapes of the illustrations as a result, for example, of manufacturingtechniques and/or tolerances, are to be expected. Thus, the exampleembodiments of the present disclosure should not be construed asnecessarily limited to the particular shapes of regions illustratedherein, but are to include deviations in shapes that result, forexample, from manufacturing.

Any and/or all elements, as disclosed herein, can be formed from a same,structurally continuous piece, such as being unitary, and/or beseparately manufactured and/or connected, such as being an assemblyand/or modules. Any and/or all elements, as disclosed herein, can bemanufactured via any manufacturing processes, whether additivemanufacturing, subtractive manufacturing and/or other any other types ofmanufacturing. For example, some manufacturing processes include threedimensional (3D) printing, laser cutting, computer numerical control(CNC) routing, milling, pressing, stamping, vacuum forming,hydroforming, injection molding, lithography and/or others.

Any and/or all elements, as disclosed herein, can include, whetherpartially and/or fully, a solid, including a metal, a mineral, aceramic, an amorphous solid, such as glass, a glass ceramic, an organicsolid, such as wood and/or a polymer, such as rubber, a compositematerial, a semiconductor, a nano-material, a biomaterial and/or anycombinations thereof. Any and/or all elements, as disclosed herein, caninclude, whether partially and/or fully, a coating, including aninformational coating, such as ink, an adhesive coating, a melt-adhesivecoating, such as vacuum seal and/or heat seal, a release coating, suchas tape liner, a low surface energy coating, an optical coating, such asfor tint, color, hue, saturation, tone, shade, transparency,translucency, non-transparency, luminescence, anti-reflection and/orholographic, a photo-sensitive coating, an electronic and/or thermalproperty coating, such as for passivity, insulation, resistance orconduction, a magnetic coating, a water-resistant and/or waterproofcoating, a scent coating and/or any combinations thereof.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this disclosure belongs. Theterms, such as those defined in commonly used dictionaries, should beinterpreted as having a meaning that is consistent with their meaning inthe context of the relevant art and should not be interpreted in anidealized and/or overly formal sense unless expressly so defined herein.

Furthermore, relative terms such as “below,” “lower,” “above,” and“upper” may be used herein to describe one element's relationship toanother element as illustrated in the accompanying drawings. Suchrelative terms are intended to encompass different orientations ofillustrated technologies in addition to the orientation depicted in theaccompanying drawings. For example, if a device in the accompanyingdrawings is turned over, then the elements described as being on the“lower” side of other elements would then be oriented on “upper” sidesof the other elements. Similarly, if the device in one of the figures isturned over, elements described as “below” or “beneath” other elementswould then be oriented “above” the other elements. Therefore, theexample terms “below” and “lower” can, therefore, encompass both anorientation of above and below.

The description of the present disclosure has been presented forpurposes of illustration and description, but is not intended to beexhaustive or limited to the present disclosure in the form disclosed.Many modifications and variations will be apparent to those of ordinaryskill in the art without departing from the scope and spirit of thepresent disclosure. Exemplary embodiments were chosen and described inorder to best explain the principles of the present disclosure and itspractical application, and to enable others of ordinary skill in the artto understand the present disclosure for various embodiments withvarious modifications as are suited to the particular use contemplated.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. The descriptions are not intended to limit the scope of thetechnology to the particular forms set forth herein. Thus, the breadthand scope of a preferred embodiment should not be limited by any of theabove-described exemplary embodiments. It should be understood that theabove description is illustrative and not restrictive. To the contrary,the present descriptions are intended to cover such alternatives,modifications, and equivalents as may be included within the spirit andscope of the technology as defined by the appended claims and otherwiseappreciated by one of ordinary skill in the art. The scope of thetechnology should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.

What is claimed is:
 1. A method for producing a fibrillated tissuematrix, comprising: placing a carrier liquid into a pressure vessel;introducing tissue into the carrier liquid; pressurizing the carrierliquid and said tissue within the pressure vessel to a critical pressurein the range of from 100 to 600 MPa; selectively controlling atemperature of the contents within the pressure vessel so as to preservebiological components of the tissue during a boiled liquid expandingvapor explosion (BLEVE) process; and thereafter, depressurizing thepressure vessel to trigger the BLEVE process to produce the fibrillatedtissue matrix and a vaporized fluid comprising at least a portion of thebiological components.
 2. The method according to claim 1, furthercomprising: capturing the vaporized fluid; and condensing the vaporizedfluid into a biological constituent distillate.
 3. The method accordingto claim 2, further comprising: dehydrating the fibrillated tissuematrix; and rehydrating the dehydrated fibrillated tissue matrix withthe biological constituent distillate to create an enriched fibrillatedmatrix.
 4. The method according to claim 3, further comprising furtherenriching any of the enriched fibrillated matrix or the dehydratedfibrillated tissue matrix with any of a tissue growth enhancing product,a medicament, a filler, or any combinations thereof.
 5. The methodaccording to claim 1, further comprising fabricating an allograftimplant using the fibrillated tissue matrix.
 6. The method according toclaim 5, wherein the tissue is obtained from a patient receiving theallograft implant such that the allograft implant is a chimeric graftthat is cytokine autologous.
 7. The method according to claim 1, whereinthe temperature includes a range of temperatures of approximately 35-41degrees Centigrade, inclusive allowing for pyrogenic cytokines and theireffective activity on cell shedding and reaction during the BLEVEprocess.
 8. A method for producing a fibrillated tissue matrix,comprising: subjecting tissue in a carrier liquid to a fibrillationpressure in the range of from 100 to 600 MPa in a pressure vessel whilemaintaining a temperature of the tissue and the carrier liquid to at orbelow a safe zone temperature that reduces deleterious damage to tissuecomponents; depressurizing the vessel to induce a phasic shift and rapidrelease of water and biological components from said tissue through adisruptive boil and tissue explosion process to produce the fibrillatedtissue matrix; and recapturing the water and biological components. 9.The method according to claim 8, wherein prior to the step of subjectingtissue in a carrier liquid to a fibrillation pressure, the methodfurther comprises: reducing a temperature of said tissue to a fracturingtemperature; and applying a mechanical force to fracture the tissue.